Trial Outcomes & Findings for A Controlled Laboratory Study of the Effects on Cue-Induced Craving in Dependent Smokers (NCT NCT00901459)

Results Overview

Cigarette craving was assessed orally during each rTMS Session, before and after each stimulus presentation and cigarette smoking with a brief version of the Shiffman-Jarvik questionnaire (14), which contained items assessing cigarette craving using the following subscale: CRAVING ("urges to smoke," "miss a cigarette," and "crave cigarettes"), MOOD ("calm," "tense," and "irritable"), AROUSAL ("wide awake," "able to concentrate"), and HUNGER ("feel hungry"). The scale for the Shiffman-Jarvik questionnaire is a Likert item scale with measurements 1-Not at All; 2-Very Little; 3-A Little; 4-Moderately; 5- A Lot; 6-Quite A Lot and 7-Extremely. The change in craving for cigarettes after smoking cues versus neutral cues using the parenthetical items listed above with the subscale CRAVING were used to determine the primary outcome. A negative value represents a decrease in reported cigarette craving.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

Following exposure to in vivo cues

Results posted on

2013-01-25

Participant Flow

The first participant was consented on 5/12/2009 and the final participant on 6/22/2010 at the Duke Center for Nicotine and Smoking Cessation Research. During the recruitment phase of the study 148 potential subjects were consented and 7 read the consent form and chose not to participate.

Of the 148 participants that were consented for this study only 21 subjects met study criteria the others were excluded from participation for the following reasons: 70-Did Not Meet Inclusion Criteria 6-Lab Results 6-Lost to Contact 26-Medical 14-Met exclusion criteria 3-Refused to participate 2-Unable To Meet Study Requirements

Participant milestones

Participant milestones
Measure	All Study Participants Active: rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Superior Frontal Gyrus Location Control: rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Motor Cortex Frequency Control: rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus
Overall Study STARTED	21
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	All Study Participants Active: rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Superior Frontal Gyrus Location Control: rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Motor Cortex Frequency Control: rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus
Overall Study Withdrawal by Subject	6

Baseline Characteristics

A Controlled Laboratory Study of the Effects on Cue-Induced Craving in Dependent Smokers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=21 Participants Active: rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Superior Frontal Gyrus Location Control: rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Motor Cortex Frequency Control: rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	39.9 years STANDARD_DEVIATION 8.88 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: Following exposure to in vivo cues

Population: A repeated measures design exposed participants to three different rTMS conditions over 3 separate visits, with order counterbalanced using latin square design.

Cigarette craving was assessed orally during each rTMS Session, before and after each stimulus presentation and cigarette smoking with a brief version of the Shiffman-Jarvik questionnaire (14), which contained items assessing cigarette craving using the following subscale: CRAVING ("urges to smoke," "miss a cigarette," and "crave cigarettes"), MOOD ("calm," "tense," and "irritable"), AROUSAL ("wide awake," "able to concentrate"), and HUNGER ("feel hungry"). The scale for the Shiffman-Jarvik questionnaire is a Likert item scale with measurements 1-Not at All; 2-Very Little; 3-A Little; 4-Moderately; 5- A Lot; 6-Quite A Lot and 7-Extremely. The change in craving for cigarettes after smoking cues versus neutral cues using the parenthetical items listed above with the subscale CRAVING were used to determine the primary outcome. A negative value represents a decrease in reported cigarette craving.

Outcome measures

Outcome measures
Measure	Active n=15 Participants rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Superior Frontal Gyrus	Location Control n=15 Participants rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Motor Cortex	Frequency Control n=15 Participants rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTMS Location: Superior Frontal Gyrus
Change in Craving for Cigarettes After Smoking Cues Versus Neutral Cues Using a Repeated Measure Design.	-.18 units on a scale Standard Error .95	.12 units on a scale Standard Error 1.30	1.29 units on a scale Standard Error 1.52

SECONDARY outcome

Timeframe: After smoking a cigarette through the controlled puff volume apparatus during rTMS

Craving reduction was assessed orally by an item on the cigarette evaluation questionnaire ("Did it immediately reduce your craving for cigarettes?") after smoking presentations through the controlled puff volume apparatus.

Outcome measures

Outcome measures
Measure	Active n=15 Participants rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Superior Frontal Gyrus	Location Control n=14 Participants rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Motor Cortex	Frequency Control n=15 Participants rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTMS Location: Superior Frontal Gyrus
Change in Craving for Cigarettes After Controlled Smoke Presentations.	-.18 units on a scale Standard Deviation .95	.12 units on a scale Standard Deviation 1.30	1.29 units on a scale Standard Deviation 1.52

Adverse Events

Active

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Location Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Frequency Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jed E. Rose, Ph.D.

Duke Center for Nicotine and Smoking Cessation Research

Phone: 919-668-5055

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place